Design Assurance Engineer

Medical Engineering Consultants (MEC); Maple Grove (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

AAP/EEO DFWP

Job summary

Medical Engineering Consultants (MEC) is hiring a Contract Design Assurance Engineer in Minnesota to lead design quality, DHF, risk management and post-market processes within a large medical device setting. The role emphasizes collaboration across engineering, QA and manufacturing to ensure robust compliance and continuous improvement.

Ideal candidates have extensive QA leadership experience with interventional cardiology exposure, a strong quality system background, and hands-on DHF

Qualifications

• 9–13 years of experience with BS
• 7–11 years with MS
• 4–8 years with PhD

Responsibilities

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
• Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Skills

Design quality leadership

Interventional cardiology experience

Quality systems knowledge

Cross-functional mentoring

Problem solving

Education

BS

MS

PhD

Job description

Job 2949 - Design Assurance Engineer - Contract located in Hennepin County, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages. MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts). MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Onsite

Job Purpose

Experience with design quality roles in the past. Experience with interventional cardiology. Experience within a large medical device company. Previous experience with Our Client's quality system is highly desired. At minimum 5 years of experience with design history file (DHF), risk management and post market complaint medical device processes.

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Develops, establishes and maintains quality engineering methodologies, systems and practices which meet our Client's customer and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational or system/services support.

Functional Engineering Roles Include

Design Assurance, Operations, Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.

Key Responsibilities

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
• Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Quality Systems Duties And Responsibilities

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

• 9 - 13 Years with BS
• 7 - 11 Years with MS
• 4 - 8 Years with PhD

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.